Effects of a disposable home electro-stimulation device (Pelviva) for the treatment of female urinary incontinence: a randomised controlled trial

Aims To compare current General Medical Practitioner treatment as usual (TAU) for the treatment of female urinary incontinence with a novel disposable home electro-stimulation device (Pelviva). Methods Open label, Primary Care post-market evaluation. 86 women with urinary incontinence were randomly assigned to one of two 12-week treatments: TAU or Pelviva for 30 min every other day plus TAU. Outcome measures included ICIQ-UI (primary), PISQ-IR, PGI-S / PGI-I and FSFI (secondary) at recruitment and immediately after intervention, 1-h pad test at recruitment and usage diaries throughout. Results Pelviva plus TAU produced significantly better outcome than TAU alone: 3 versus 1 point for ICIQ-UI (Difference − 1.8 95% CI: − 3.5 to − 0.1, P = 0.033). Significant differences were also observed for PGI-I at both 6 weeks (P = 0.001) and 12 weeks (P < 0.001). In the Pelviva group, 17% of women described themselves as feeling very much better and 54% a little or much better compared to 0% and 15% in the TAU. Overall PISQ-IR score reached statistical significance (P = 0.032) seemingly related to impact (P = 0.027). No other outcome measures reached statistical significance. Premature termination due to COVID-19 meant only 86 women were recruited from a sample size of 264. TAU did not reflect NICE guidelines. Conclusions This study suggests Pelviva is more successful than TAU in treating urinary incontinence in Primary Care. The study had reduced power due to early termination due to COVID-19 and suggests TAU does not follow NICE guidelines.

Clinical profile of Female Urinary Incontinence: A Hospital Based Study

Aim: To determine the prevalence of urinary incontinence of women attending gynae outdoor patient department. Method: It is a prospective cross sectional study conducted at Paropakar Maternity and Women’s Hospital for three months. Types of incontinence, their presentation, associated factors, age and parity were the variables studied. Data were analyzed by descriptive statistics. Results: Out of 950 gynaecological out-patients, 97 had urinary incontinence(10.2%); 34.1% were in 50- 59 years and 37.2% were multipara. Stressurinary incontinence (SUI) was the most common incontinence (56.7%) followed by mixed urinary incontinence (22.7%) and urge urinary incontinence (20.6%). Common complaints were leakage during coughing (63.6%) and sneezing(18.2%) in SUI;urgency and frequency were main problem in mixed and urge urinary incontinence. Three-fourth cases had associated medical conditions and rest had gynecological factors. Conclusions: Urinary incontinence is common in the fifth decade of life of women and more than half had stress incontinence.